Quality Systems & Opex Manager (change Management)

Indivior

Richmond, VA, United States
Not specified; not specified; competitive pto + co...
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Bachelor of science in scientific discipline
Minimum 8 years quality experience in regulated industry
Knowledge of gmps and international regulatory standards
** Indivior is seeking a Quality Systems & OPEX Manager specializing in Change Management to enhance the pharmaceutical quality system and drive a culture of quality. The position is hybrid and requires extensive experience in quality management within regulated industries, focusing on compliance, process improvement, and cross-functional collaboration. **

Job Summary

  • This role is a key part of the global quality organization in establishing and maintaining Quality Systems while driving a culture of quality at Indivior.
  • The incumbent will own and lead the management of QMS Change Control, including oversight of global and local Change Control Review Boards (CCRB).
  • Indivior offers comprehensive benefits including a 401(k) match of 75% on the first 6% of contributions and profit-sharing equal to 4% of eligible pay.

Matching Summary

Match Score: 75

** Indivior is seeking a Quality Systems & OPEX Manager specializing in Change Management to enhance the pharmaceutical quality system and drive a culture of quality. The position is hybrid and requires extensive experience in quality management within regulated industries, focusing on compliance, process improvement, and cross-functional collaboration. **

Salary

Not specified; Not specified; Competitive PTO plus company closure from December 24th-January 1st; 401(k) match; Profit-sharing; Stock Purchase Plan; Comprehensive Medical, Dental, Vision, Life, Disability; Tuition reimbursement

Skills & Requirements

Must-have

  • Bachelor of Science in scientific discipline
  • Minimum 8 years quality experience in regulated industry
  • Knowledge of GMPs and international regulatory standards
  • Experience with QMS Change Control and CCRB processes
  • Proficiency in Risk Assessments for deviations and CAPA

Nice-to-have

  • Lean Six Sigma Green Belt certification
  • Project Management certification
  • Visio and eQMS software proficiency
  • IT system superuser capabilities
  • Strong negotiation and soft skills

Key Requirements

  • Bachelor of Science degree required
  • 8+ years quality experience in regulated industry
  • Must be able to travel up to 10%

Work Rights

Not specified

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